Informations générales (source: ClinicalTrials.gov)
USE OF 18FDG PET-CT TO PREDICT THE RESPONSE OF MANDIBULAR OSTEORADIONECROSIS TO THE PENTOCLO PROTOCOL WITH DOCUMENTED ANTIBIOTHERAPY (PENTOTEP)
Observational
Gustave Roussy, Cancer Campus, Grand Paris (Voir sur ClinicalTrials)
juin 2019
juin 2024
29 juin 2024
This study is created in order to refine and reduce the duration between the medical and
surgical therapeutic sequences (when the surgery is necessary) in these fragile patients
knowing that conventional radiological changes can only be observed with a delay
comprised between 3 and 6 months starting from observed clinical changes.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Aina Dinnoo, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
1. Patients with symptomatic osteoradionecrosis with a PENTOCLO protocol indication
(decided in a multi-disciplinary staff).
2. Patient should understand to any protocol-specific procedures performed. Patient who
did not object to participate after being informed of the study. Patient should be
able and willing to comply with study visits and procedures as per protocol.
3. Patients must be affiliated to a social security system or beneficiary of the same.
4. Patients must be over 18 years old (legal age).
1. Patients with symptomatic osteoradionecrosis with a PENTOCLO protocol indication
(decided in a multi-disciplinary staff).
2. Patient should understand to any protocol-specific procedures performed. Patient who
did not object to participate after being informed of the study. Patient should be
able and willing to comply with study visits and procedures as per protocol.
3. Patients must be affiliated to a social security system or beneficiary of the same.
4. Patients must be over 18 years old (legal age).
1. Excluded forms of the disease: mandibular osteoradionecrosis complicated by
mandibular fracture and / or hyperalgesic (resistant to analgesic treatment of stage
III).
2. Contraindications specific to the treatment under study (allergy to one of the
PENTOCLO treatments, contraindication to 18FDG PET-CT).
3. Associated pathology that contra-indicate on of the PENTOCLO treatment.
4. Pregnant woman, declaring likely to be pregnant or breastfeeding. Chilbearing age
women must declare not being pregnant and use effective contraception.
5. Impossibility to submit to the medical follow-up of the test for geographical,
social or psychological reasons.
6. Patient under guardianship or deprived of his liberty by a judicial or
administrative decision or unable to express its opposition to participating in the
study.